1. Technical Field
The present invention relates to the field of medical items used during surgery, and more particularly, to surgical barriers and drapes, and even more particularly to such drapes having fenestrations for accessing the surgical sites.
2. Description of the Related Art
It is well known to cover patients undergoing surgery with surgical drapes to create a sterile barrier around the surgical site. Some surgical drapes have fenestrations, or pre-defined openings, used during the procedures for one of two primary purposes, namely, to give access through the drape to the surgical site or to accommodate a portion of the patient's anatomy. In either case, the fenestration provides an opening in the drape to isolate the surgical site, and thereby create a sterile field between the body portion containing the surgical site and the remainder of the patient's body.
Surgical drapes are generally structured so that the fenestrations, and other openings, are shaped and sized in contemplation of either providing surgical access to a specific anatomical site or accommodating an anatomical feature of the patient. Thus, for example, a fenestration for an arm would be positioned in the drape near the proximal end and offset to one lateral side, and it would be dimensioned according to a standardized arm circumference measurement.
In addition to the general sizing and positioning of the fenestration in the surgical drape, drapes for some surgical procedures require special accommodations. For example, extra large or multiple fenestrations may be needed for procedures requiring multiple surgical sites, such as the multiple instrument entry sites required in certain endoscopic procedures. For example, bariatric procedures typically require six or more incisions, one or more for the camera(s) and the rest for the trocars or other working instruments. In bariatric procedures, it is common for the surgeon to make an incision located according to the position of the xiphoid at the base of the sternum. Others are made in the abdomen relative to the navel or other anatomical features.
The shape of the fenestration can be an important factor, particularly for specialized drapes designed for these types of surgical procedures, so that the appropriate anatomical point of interest can be identified readily and the fenestration can be positioned properly for access to the intended surgical site. Typical surgical drapes with fenestrations for accessing the surgical sites have standard shaped fenestrations, such as generally rectangular or circular. Fenestrations for accommodating anatomical features such as limbs are typically circular.
While rectangular and circular fenestrations are common, it is known for surgical drapes to have other, less standard shaped fenestrations. For example, U.S. Pat. No. 3,800,790 to Collins discloses an elliptical fenestration, and U.S. Pat. No. 4,957,120 to Grier-Idris discloses a racetrack shaped fenestration. U.S. Pat. No. 4,489,720 to Morris, et al. and U.S. Pat. No. 5,394,891 to Mills, et al. both disclose a triangular fenestration. U.S. Pat. No. 5,161,544 to Morris discloses a similar triangular fenestration albeit with rounded corners. These patents largely disregard the configuration of the fenestration itself, instead concentrating on the sealing and construction of the panel in which the fenestration is located, since preventing the sterile field at the surgical site from being compromised is a primary concern and is thus often given a priority in design. Morris, et al. disclose that the fenestration could be any desirable configuration, and merely note without explanation that a triangular fenestration is “particularly useful” in cesarean section procedures (col. 3, lines 9-12).
Hafer, et al. disclose, in U.S. Pat. No. 6,199,553, a drape with a separately attachable absorbent reinforcement pad both of which have a five-sided fenestration. The fenestration in the reinforcement pad is formed by cutting and folding back sections of the pad. The folded back sections of the pad provide a “landing zone” for affixing a fluid collection device to the drape. The bottom surface of the reinforcement pad has a film backing that is more suitable for adhesives such that when the sections are folded back, the film surface faces up and provides a good surface for affixing the fluid collection device. The fenestration of the base sheet of the drape is thus made five-sided or “diamond” shaped merely so that the two fenestrations are the same shape and align after the reinforcement pad is cut and the sections forming the landing zone are folded back.
There is thus a need for a surgical drape having a fenestration configured to aid in locating an anatomical point of interest and positioning the fenestration at the surgical site necessary for a given surgical procedure.